Country for PR: United States
Contributor: PR Newswire New York
Friday, January 14 2022 - 22:18
LumiraDx Lab Analysis Confirms its COVID-19 Antigen Test Detects the Omicron Variant
LONDON, Jan. 14, 2022 /PRNewswire-AsiaNet/ --

--Results from ongoing testing and monitoring of COVID-19 variants shows the 
rapid microfluidic test detects Omicron at a comparable sensitivity to other 

LumiraDx (Nasdaq: LMDX), a next-generation point of care diagnostics company, 
today announced that results from ongoing testing and monitoring of COVID-19 
variants show its SARS-CoV-2 Antigen test detects the Omicron Variant.  
In-house wet testing with live Omicron virus demonstrated that the LumiraDx 
SARS-CoV-2 Antigen test detects the Omicron variant with comparable sensitivity 
to other variants. In the original  U.S. Food and Drug Administration ("FDA") 
Emergency Use Authorization ("EUA") clinical studies, the test demonstrated 
100% agreement with RT-PCR up to Ct 33.0. These latest testing results confirm 
the company's previous announcement ( 
) based on in-silico and recombinant protein analysis of the specific mutations 
in the Omicron variant that it was confident that the performance of its 
antigen and molecular tests will not be impacted by these mutations.

Logo -

Nigel Lindner, PhD, Chief Innovation Officer at LumiraDx commented, "Testing is 
a critical tool to control the spread of the virus and we have been committed 
to conducting research that confirms the sensitivity of our tests as soon as 
new variants emerge. We continuously monitor for COVID-19 variants and evaluate 
new ones as they appear through our in-house testing as well as through our 
collaborations with laboratory partners globally. The ability of our test to 
detect Omicron and other variants of concern, combined with both CE Marking and 
EUA from FDA with the intended use  that includes the screening of asymptomatic 
individuals makes the LumiraDx SARS-CoV-2 Antigen test a valuable tool at this 
stage of the pandemic."  

About the LumiraDx SARS-CoV-2 Antigen Test
The LumiraDx SARS-CoV-2 Antigen test has not been FDA cleared or approved, but 
has been authorized by FDA under an EUA for use by authorized laboratories. The 
product has been authorized only for the detection of proteins from SARS-CoV-2, 
not for any other viruses or pathogens. The emergency use of the product is 
only authorized for the duration of the declaration that circumstances exist 
justifying the authorization of emergency use of in vitro diagnostics for 
detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal 
Food, Drug, and Cosmetic Act, 21 U.S.C. Section 360bbb- 3(b)(1), unless the 
declaration is terminated or authorization is revoked sooner.  

About LumiraDx
LumiraDx (Nasdaq: LMDX) is a next-generation point of care diagnostics company 
that is transforming community-based healthcare. Founded in 2014, LumiraDx 
manufactures and commercializes an innovative diagnostic Platform that supports 
a broad menu of tests with lab comparable performance at the point of care. 
LumiraDx diagnostic testing solutions are being deployed by governments and 
leading healthcare institutions across laboratories, urgent care, physician 
offices, pharmacies, schools, and workplaces to screen, diagnose, and monitor 
wellness as well as disease. LumiraDx has, on the market and in development, 
30+ tests covering infectious diseases, cardiovascular diseases, diabetes, and 
coagulation disorders, all on the LumiraDx Platform. In addition, LumiraDx has 
a comprehensive portfolio of fast, accurate, and cost-efficient COVID-19 
testing solutions from the lab to point of need. 

LumiraDx is based in the UK with more than 1600 employees worldwide. Further 
information on LumiraDx and the LumiraDx Platform is available at

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of 
the U.S. Private Securities Litigation Reform Act of 1995, including statements 
regarding the benefits of the LumiraDx SARS-CoV-2 Antigen test and its ability 
to detect variants and mutations of COVID-19. These statements involve risks, 
uncertainties and other factors that may cause actual results, levels of 
activity, performance or achievements to be materially different from the 
information expressed or implied by these forward-looking statements, 
including, among others, general economic, political and business conditions; 
the effect of COVID-19 on LumiraDx's business and financial results; 
maintaining EUA authorization for the LumiraDx SARS-CoV-2 Antigen Test (as 
re-issued); and those factors discussed under the header "Risk Factors" in the 
Proxy Statement and Prospectus filed pursuant to Rule 424(b)(3) with the 
Securities and Exchange Commission ("SEC") on September 3, 2021 and other 
filings with the SEC. Although LumiraDx believes that it has a reasonable basis 
for each forward-looking statement contained in this press release, LumiraDx 
cautions you that these statements are based on a combination of facts and 
factors currently known by it and its projections of the future, about which it 
cannot be certain. LumiraDx undertakes no obligation to update or revise the 
information contained in this press release, whether as a result of new 
information, future events or circumstances or otherwise.

Media Contact 
Colleen McMillen  
SOURCE: LumiraDx